06/02/18

Dengue vaccination: when being the first is a bad idea

A girl is vaccinated against measles, in Barangay 91, Tacloban, Leyte. The Philippine Government, with support from UNICEF and the World Health Organization
Copyright: UNICEF East Asia & Pacific/Flickr

Speed read

Sanofi faces lawsuit after mass dengue vaccination in the Philippines

The government’s bold move for early adoption proved risky

Controversy leaves people with general mistrust of public health programmes

When the Philippines launched its dengue vaccination programme on 4 April 2016, using Sanofi Pasteur’s newly approved ‘Dengvaxia’, there was great fanfare and optimism.

This week, the Public Attorney’s Office has filed a lawsuit against the company, seeking compensation for the death of a 10-year old girl it says has died as a result of the vaccine.

It follows an investigation of the halted programme by the Philippine Senate. Meanwhile, threats of more class action suits against Sanofi continue, with the health ministry itself threatening to sue the company for refusing to refund the PhP3.5 billion (US$70 million).

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And, Senate Blue Ribbon Committee chair Richard Gordon said in a radio interview this week that the committee is considering filing of anti-graft cases against former President Benigno Aquino III, Budget Secretary Florencio Abad and Health Secretary Janette Garin.

Some scientists are pitching in, explaining what Sanofi Pasteur and the former health department officials have done. On the other hand, a group of 58 medical doctors and scientists, headed by former Health Ministers Esperanza Cabral and Manuel Dayrit, have issued a statement calling for calm.

But as Philippine scientists and politicians fight over the failure of Asia’s first mass dengue vaccination programme, the biggest casualty may be people’s trust and confidence in vaccination and other government-led public health programmes as an effective way to fight diseases.

Public trust in vaccination has taken a beating, helped by the media’s sensational coverage of suspected dengue-vaccine related child deaths. Unfortunately, the mistrust has extended to other public health programmes: news stories report that families in poor communities are now refusing to take part in free, basic child care programmes such as deworming.

The furore began on 29 November 2017, when Sanofi Pasteur warned in a statement that people inoculated with the dengue vaccine would be at “severe risk” if they had not been previously infected with the virus. Dengvaxia, according to the manufacturer, gives “persistent protective benefit against dengue,” but only for those who have been previously infected with the disease.

Almost immediately after the news came out, a number of parents came forward claiming that their children either got sick or died as a result of the vaccination.

On 22 December 2015, the Philippines became the first Asian country — and second in the world next to Mexico — to license Sanofi Pasteur’s vaccine, Dengvaxia.

On 4 April 2016, just four months later, the Philippines launched its school-based mass vaccination programme. It went ahead with the programme without the WHO pre-qualification that is normally required. However, I am told that this decision was based on the advice of the Strategic Advisory Group of Experts (SAGE), a 15-member panel of independent experts, which provides recommendations to the WHO on global vaccine policies.

On 24 April 2016, or 20 days later, a total of 204,397 vaccinations were completed, 362 of which had adverse reactions. By the following year, a total of 837,000 people, mostly children, had been vaccinated, all of whom come from regions where dengue is endemic.

But on 29 November 2017, Sanofi Pasteur issued a statement warning that people who got vaccinated with Dengvaxia would be at “severe risk” if they had not been previously infected with the virus. The warning was based on a new analysis of six years’ worth of data from clinical studies done by the company.

Immediately after that, the Philippine health secretary Francisco Duque said in a press conference that the dengue vaccination programme was being halted, and a review had been ordered. He told SciDev.Net in an interview that there are no plans to resume the programme. The health department was also looking at 24 deaths possibly linked to the mass vaccination, added Duque.

Political fallout

The Philippine media has kept the Dengvaxia issue in the headlines ever since Sanofi Pasteur made its announcement. Both broadcast and social media have sensationalised the story, airing pictures of mothers crying over the deaths of children they say are attributed to dengue.

Views on social media are especially critical of Sanofi Pasteur and some health officials, often voicing negative opinions about vaccination itself.

The Philippine Senate, through its investigative and anti-corruption Blue Ribbon Committee, has conducted several hearings on the scandal, with no less than former Philippine President Benigno Aquino III among those who have testified and stand to face charges.

Lessons learned

What have we learned from this fiasco?
First, we are reminded again that haste makes waste. I confess to being gung-ho when I wrote about the launch of the vaccination programme in 2016. It seemed a bold and pioneering move, considering the number of cases in the Philippines.

It is easy to overlook the dangers of a new technology being introduced — dangers which should be heeded especially when the technology involves the human body. The Philippine government could have been more conservative in adopting the new vaccine, especially in this case, since it involves children.

And why start at such a massive scale? Testing the vaccine on a smaller sample size as an extension of the clinical trials underway, while Sanofi Pasteur completed its own tests, would have been ideal.

Now, the public is wary of other health programmes — and the scepticism could extend to scientists who will be talking of new technologies that could affect health, like GM foods. On January 31st, a group of leading Filipino physicians and scientists published a statement in leading newspapers expressing concern about the misinformation generated by the Dengvaxia controversy, which they said “has eroded public confidence in the country’s vaccination programme and other public healthcare endeavours”.

“If this trend continues, then we may find ourselves faced with outbreaks of debilitating and life-threatening diseases that we have already been able to control through our vaccination programmes,” the statement emphasised.

Indeed, the Philippines has the distinction of being the first country in the world to introduce Dengvaxia in a mass vaccination programme — but it is now paying the price for this. In hindsight, it looks like Filipino children became unwitting guinea pigs in the rush to roll out a new dengue vaccine, with the scientific and health community’s reputation taking a hit as well.

Crispin Maslog, a former journalist with Agence France-Presse, is an environmental activist and former science professor at Silliman University and University of the Philippines Los Baños. He is a founding member and now Chair of the Board of the Asian Media Information and Communication Centre.